This major FDA document was released and widely distributed in early August 2014. It sets out a new course in Substantial Equivalence. It sets aside established doctrine since 1976. It adds the benefit /risk based on Technological Characteristics. What this fails to explain is even IF a device meets all ISO harmonized testing and submits clinical data, FDA can refuse a device that truly is Substantial Equivalence just because of some intangible benefit/risk ration that only FDA knows. This open all submissions up to any kind of scrutiny FDA chooses to apply even though the 1976 FDA CDRH Act that U.S. Congress passed said if a device is Substantial Equivalence then FDA must clear it. This changes the calculation for what FDA can parse in deciding what is S.E. This pushes 510(k)s (Class II) closer to the higher level scrutiny of the PMAs (Class III).

Benefit vs risk evaluation
with different Technological Characteristics

Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] with Different Technological Characteristics Draft Guidance for Industry and Food and Drug Administration Staff DRAFT GUIDANCE

This guidance document is being distributed for comment purposes only. Document issued on July 15, 2014.

http://www.fda.gov/medicaldevices/deviceregulation
andguidance/guidancedocuments/ucm282958.htm